Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

Sporotrichosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004938
• Other study ID #: 199/11815
• Secondary ID: NIAID-MSG-11815
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 8, 2006
• Start date: August 1996
• Est. completion date: August 1996

Study information

• Verified date: April 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVE:

I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

Description:

PROTOCOL OUTLINE:

Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Presumptive evidence of sporotrichosis Culture-proven sporotrichosis determined on study Relapsing disease following antifungal therapy eligible if culture positive for Sporothrix schenckii prior to entry No life-threatening disease No central nervous system sporotrichosis --Prior/Concurrent Therapy-- No concurrent drugs known to react with fluconazole No more than 3 days of systemic antifungals for current sporotrichosis episode --Patient Characteristics-- Hepatic: Liver function tests no greater than 5 times normal Other: No HIV infection No pregnant or nursing women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sporotrichosis

Intervention

Drug:
• fluconazole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	University of Alabama at Birmingham

References & Publications (1)

Kauffman CA, Pappas PG, McKinsey DS, Greenfield RA, Perfect JR, Cloud GA, Thomas CJ, Dismukes WE. Treatment of lymphocutaneous and visceral sporotrichosis with fluconazole. Clin Infect Dis. 1996 Jan;22(1):46-50. — View Citation